The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies


Hyatt Regency Boston

One Avenue de Lafayette

Boston, MA 02111

Date & Time

Start Date: 06/28/2022
Start Time: 11:45 a.m. ET
End Time: 12:45 p.m. ET


Blake Coblentz will be speaking at the American Conference Institute's Biosimilars & Innovator Biologics conference. Subsequent to the Federal Circuit’s skinny label ruling in GSK v. Teva, the District of Delaware in Amarin v. Hikma (D. Del. 2022) embraced a narrower approach in dismissing an induced infringement claim based on an allegedly inadequate skinny label carve out. The Delaware court also examined the novel question of whether a health insurer’s formulary placement of the drug in question induced infringement of method-of-use patents. Further, confirming that without any bright line rules, and absent a decision from the U.S. Supreme Court or legislation, the fate of the skinny label remains in the balance.

  • Considering whether the language of press releases, web pages and other marketing materials require more scrutiny
  • Analyzing potential liability faced by insurers for placement of skinny label on formularies
    • Does liability exist for induced infringement by listing a skinny label on a formulary
    • Taking stock of the potential impact to patients
  • Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label


Share on LinkedIn


W. Blake Coblentz

Co-Chair, Hatch-Waxman & Biologics
Vice Chair, Intellectual Property

(202) 912-4837

Related Practices